Local Contact For Pharmacovigilance With Estonian And English Language

Iqvia; Madrid; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

IQVIA is seeking a Local Contact for Pharmacovigilance based in Europe; role supports customers needing pharmacovigilance services for their products. Work arrangement can be home-based, hybrid, or office-based across Europe.

The ideal candidate has a life-sciences degree, 3 years in clinical safety/pharmacovigilance, and fluent English with native Estonian proficiency; strong regulatory knowledge and risk management experience are a plus.

Qualifications

• Degree in life-science, medicine, pharmacy or nursing or equivalent.
• 3 years of relevant experience in clinical safety/pharmacovigilance.
• Strong English (C1) and Estonian (C2/native) skills.

Responsibilities

• Respond to requests from Competent Authorities to evaluate benefits and risks of medicines, including safety data.
• Stay up to date with local regulatory requirements and risk management plans.
• Manage project materials, SOW, and maintain project files/templates.
• Provide regular reports to project manager on metrics, SOW changes, and customer requests.
• Communicate monthly updates to EU QPPV/designee and regulatory reports.

Skills

English C1

Estonian C2

Pharmacovigilance knowledge

Education

Bachelor's degree in life-science/medicine/pharmacy or nursing

Job description

Local Contact for Pharmacovigilance with Estonian and English language As the Local Contact for Pharmacovigilance, you will act as local contact for Pharmacovigilance for customers requiring the services for their product(s). This role can be conducted either Home Based / Hybrid / Office based from anywhere in Europe - the choice is yours.

RESPONSIBILITIES

• Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal products.
• Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
• Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates.
• Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; communicate and document project issues to project team members and department management in a timely manner;
• Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.
• Support pharmacovigilance operations as required.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.
• 3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.
• Excellent written and verbal skills in English (min. C1) and Estonian language (min. C2 / native).
• In-depth knowledge of applicable global, regional and local regulatory requirements, International Conference on Harmonization (ICH) guidelines, and relevant Standard Operating Procedures (SOPs).
• Very good knowledge of the pharmacovigilance legal framework in Estonia.
• Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product.
• Demonstrate an understanding of compliance and of quality management systems.

#LI-Remote #LI-Hybrid #LI-Onsite IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at [https://jobs.iqvia.com](https://jobs.iqvia.com)